Prucalopride Prior to Small Bowel Capsule Endoscopy

• Status: Unknown status
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Small bowel capsule endoscopy is a test used to investigate for any abnormalities in the small bowel. The small bowel is about 4 meters long. The battery time of the capsule is about 8 hours. During this time the capsule takes pictures as it passes through the small bowel. In about 15-20% of capsule tests the battery expires before the capsule passes through the entire small bowel into the colon. Incomplete tests indicate that a variable portion of small bowel was not visualized. Incomplete tests are associated with potential missing of abnormalities in the portion of small bowel that was not reached. The capsule test may often required to be repeated but the problem of incomplete examination may persist. At present no medication has been approved to increase the rate of complete capsule tests.

Prucalopride is a medication that has been approved in Canada and Europe for the treatment of chronic idiopathic constipation. Animal and human studies suggested that prucalopride may enhance the movement of the stomach and the small bowel. A recent presentation at a medical meeting suggested that prucalopride may accelerate the passage of the capsule camera through the small bowel without increasing the chance to miss a lesion in the small bowel.

The purpose of this study is to asses if the administration of a single dose of prucalopride is going to decrease the time required by the capsule to move through the small bowel.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Prucalopride

Criteria

Inclusion Criteria:

• Appropriate indication for small bowel capsule endoscopy.

• Age 19 or older.

Exclusion Criteria:

• Previous partial or complete gastric resection.

• Previous small bowel surgery in which a small bowel resection has been performed or the normal anatomy has been altered.

• Presence of ileostomy.

• The requirement for endoscopic placement of the capsule endoscopy pill because of dysphagia or gastroparesis.

• Severe renal impairment, defined by the requirement for dialysis.

• Pregnancy or breast feeding.

• Clinical or radiological suspicion of small bowel obstruction.

• Simultaneous use of a prokinetic agent within 5 days of the capsule endoscopy examination.

• Clinical hypo- or hyperthyroidism.

• Known hypersensitivity to the study drug.

• Unwillingness to sign informed consent.